Remote Senior Global Regulatory Lead - Development Strategy

Ladders; United States; Remote; USD 222,000 - 303,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

PTO & flexible schedules

401(k) with equity awards

Learning Institute access

ERGs & community engagement

Job summary

Ladders is seeking a Sr. Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy to guide regulatory strategies for complex development programs in a remote US-based role.

This senior leader will align regulatory plans with product development and business objectives, working with cross-functional teams and regional leads to anticipate risks and ensure efficient global execution. Responsibilities include leading global regulatory strategy, representing regulatory on Global

Qualifications

• Advanced degree in life sciences or related field.
• 10+ years of pharmaceutical/biotech regulatory experience.
• Experience as Global Regulatory Lead for complex development programs.
• Deep knowledge of global drug development and regulatory environments.
• Strong communication and strategic thinking capabilities.

Responsibilities

• Lead global regulatory strategy for assigned programs, aligning with product development and business goals.
• Serve as the senior regulatory representative on Global Program Teams, influencing key development decisions.
• Develop and maintain an integrated global regulatory strategy, addressing regional requirements.
• Provide strategic leadership to regional regulatory leads, ensuring alignment with global strategies.
• Identify regulatory opportunities and evaluate risks impacting program objectives.
• Offer strategic input into development plans, including clinical trial strategies and expedited pathways.
• Anticipate changes in the regulatory environment and translate them into actionable recommendations.

Skills

Regulatory strategy

Global regulatory lead

FDA/EMA/PMDA

Cross-functional leadership

Regulatory affairs

Education

MS/PhD/PharmD in life sciences

Job description

Ladders is seeking a Sr. Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy to guide regulatory strategies for complex development programs in a remote US-based role.

This senior leader will align regulatory plans with product development and business objectives, working with cross-functional teams and regional leads to anticipate risks and ensure efficient global execution. Responsibilities include leading global regulatory strategy, representing regulatory on Global